Cleaning Validation Articles

Destin A. LeBlanc Cleaning Validation Technologies, Technical Consulting Services In discussing monitoring for cleaning validation, it is important to carefully define what o­ne means by “monitoring”. As used here, the term “monitoring” refers to the routine measurements taken o­n the cleaning process that serve as indicators of whether the process is in a state of control (or considered from the opposite point of view, serve as indicators that the process either is not or may not be in a state of control). The purpose of monitoring is not to have clear evidence that the surfaces are acceptably clean. To do that, o­ne would have to sample the surfaces (much as o­ne would do in a cleaning validation protocol).

For full article Click Here

Destin A. LeBlanc,Cleaning Validation Technologies, Technical Consulting Services The questions that will be addressed in the Cleaning Memo include:“When should I measure endotoxin in a cleaning validation protocol?”“How should I sample for endotoxin?”“What acceptance criterion should I establish for endotoxin?”



For full article Click Here

For full Article Click Here

APIC Guide to Cleaning Validation in API plants

For full article Click Here

Guide to Cleaning Validation in API plants

For full article Click Here

Another question I commonly get is “What constitutes three consecutive runs for cleaning validation protocol purposes?” The basic approach to answering this question is to use the same principles o­ne uses for process validation. If I am validating a blending process in a certain manufacturing vessel, do the three validation runs have to be o­ne after the other, with no intervening product being processed? Or, in between the three manufacturing processes for the validation, am I allowed to blend other products? Most people would agree that the latter is appropriate for process validation.


For full text article Click Here

Cleaning Validation Technologies
Technical Consulting Services
Cleaning Memo for August 2004

For full article Click Here